Biologics CMC Director
Takeda
full-time
Posted on:
Location Type: Office
Location: Hayden • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $174,500 - $274,230 per year
Job Level
Lead
About the role
- Lead high-impact, high-visibility CMC projects for innovative biologics
- Provide technical and strategic leadership for CMC of late-stage or commercial biopharmaceuticals
- Own the end-to-end CMC lifecycle for Drug Substance and Drug Product
- Ensure manufacturing processes remain robust and comparable across sites
- Drive preparation and support of CMC content for regulatory submissions
- Identify and lead implementation of innovation and continuous improvement initiatives
- Collaborate with CMC Project Manager and mentor colleagues
Requirements
- Advanced degree (Master’s or higher preferred) in engineering or life sciences
- At least 10 years of experience in pharmaceutical or biopharmaceutical development/manufacturing
- Proven experience in product and process lifecycle management
- Deep technical understanding of biologics manufacturing, quality, and regulatory frameworks
- Demonstrated ability to lead complex, cross-functional initiatives
- Strong analytical and problem-solving skills
- Effective stakeholder management and communication skills
- Fluency in English; Mandarin is an advantage
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time
- up to 120 hours of paid vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biologics manufacturingCMC lifecycle managementregulatory submissionsproduct lifecycle managementprocess lifecycle managementquality frameworkstechnical leadershipinnovation implementationcontinuous improvement
Soft skills
analytical skillsproblem-solving skillsstakeholder managementcommunication skillsmentoring
Certifications
advanced degreeMaster’s degreeengineering degreelife sciences degree